College of Coastal Georgia Institutional Review Board Policy CLASS-RELATED PEDAGOGICAL/INSTRUCTIONAL College DISTINGUISHING of Coastal Georgia Policy on Class-Related Projects Involving Human Participants ASSIGNMENTS AND SERVICE-LEARNING PROJECTS FROM RESEARCH WITH HUMAN PARTICIPANTS S IGATIONS Introduction These guidelines are intended to assist instructors in differentiating pedagogical (instructional) assignments and service-learning projects from research investigations involving human participants and to establish policy and procedures for the approval of such assignments/projects. This policy is not intended to apply to independent student or faculty research projects. For Class Projects exemption, "Class Projects" refers to any class-related work that involves human participants. Even though this work is not regarded as research (defined in the federal regulations as “a systematic investigation designed to contribute to generalizable knowledge”) the Institutional Review Board (IRB) must be notified prior to initiation to ensure that it falls within the parameters given below and thus would be exempt from IRB review. A. Parameters for Determining if a Project is a Class Project: 1. NO MINORS: The Class Project cannot include minors or any other vulnerable populations (e.g. pregnant women, prisoners, those who lack the capacity to consent, non-English speaking individuals etc.). Exception: Projects conducted in established or commonly accepted educational settings, involving normal educational practices (e.g. work on regular and special education instructional strategies, or work on the effectiveness of, or the comparison among, instructional techniques, curricula, or classroom management methods). The student performing conducting the instructional project may not be the primary classroom teacher or one of the investigators. For Class Projects that take place off-campus (i.e., in a P-12 school setting) the Faculty Supervisor or Principal Investigator must submit a completed CCGA IRB Application for Inter-Institutional Research Authorization. Note: there are no blanket documents that apply here. 2. NO MORE THAN MINIMAL RISK: "Minimal risk" is the probability and magnitude of harm that is normally encountered in the daily lives of healthy individuals. This also prohibits the study of any illegal or illicit activities or the collection of private information that could put the participants at risk through a breach of confidentiality. 3. NO DECEPTION: The Class Project cannot include any deception. Individuals must be fully informed and given the opportunity to voluntarily consent to participation. 4. NO PUBLICATION/PRESENTATION to a Professional Audience: Data from class projects approved under this exemption cannot be used for publication and/or for thesis/dissertation research. Presentation/reports of classroom projects to the class must be restricted in detail so that identities, locations and other pertinent data are not revealed. Findings must not be reported beyond the CCGA classroom*. *An important note about dissemination: Dissemination of findings to a professional audience is a sufficient criterion for defining a project as “research” and thus requiring an IRB Approval for 1 1 October 2014 Research Application and approval. Dissemination includes, but is not limited to, honor's, master's, and doctoral theses; presentation at a scientific meeting or conference; submission to or publication of the findings in a scientific journal (print or electronic); Poster presentation and Internet and/or social media or other electronic postings. If the project falls under this definition of research, submission of an Application for Approval of Research with Human Participants research and approval by the Institutional Review Board is required. Contact the Chair of CCGA IRB, for guidance regarding the appropriate level of board review that must be conducted IRB@ccga.edu. 5. NO VIDEOTAPING: Audio taping is allowed only if the recording is erased upon transcription or no later than the end of the semester. The tapes must be placed in a locked and secure site, and the faculty supervisor must exercise extra caution in advising students of this practice. If a class project does not fall within the above parameters to qualify for this type of exemption, the instructor will be notified of the decision. The student/instructor may then submit an IRB Application for Review of Research that will go through the regular review and approval process. Such applications will be reviewed in the order in which they were received and will not be eligible for the fast track exemption accorded to class projects that fall under this policy. Faculty Supervision • Instructors are advised to discuss these guidelines with students before the Instructional assignment/project begins so informed decisions can be made about whether IRB review is needed. • If even the slightest chance exists that an instructional assignment/project may fall under the definition of research outlined in this document, or if there is the possibility that the data may be published and/or disseminated in any manner, students/instructors are advised to submit the appropriate Request for Approval of Human Subjects Research to the IRB for review and approval. • Please remember that IRB approval of a research protocol cannot be granted retroactively under any circumstances. Data obtained without approval cannot be disseminated publically as part of any research with human participants and should be destroyed. • When overseeing instructional assignments/projects that do not fall under the definition of research and thus qualify as a Class Project as outlined in this document, instructors should require students to identify the project as a class project. Labeling such projects as research is inaccurate and misleading for the students, as well as for others with whom the students may interact as a necessary component of completing the assignment. • When overseeing Class Projects, instructors are asked to advise students that any data from human participants that are collected or analyzed MUST NOT contain personal identifying information when such information is not required for completion of the assignment/project. • Instructors are ultimately responsible for the ethical behavior of their students in conducting Class Projects with human participants. College of Coastal Georgia requires that all classroom activities involving human participants receive prior approval from the Faculty Instructor of Record. The IRB reserves the right to require additional information at any time regarding group and/or specific projects. • Faculty instructors should review the CCGA IRB Student Application for Approval of Class Projects with Human Participants for each student, maintain a copy of this form in their class records, and require each student (or group) to submit a form for each individual Class Project to the IRB for record keeping purposes. • Faculty instructors MUST also complete an CCGA IRB Faculty Exemption for Class Projects and 2 1 October 2014 forwarding a hard copy with signatures, together with the class roll, and a copy of each student’s (group’s) Student Application for Approval of Class Projects to the IRB Administrator in the Office of Academic Affairs prior to the conduct of the student projects. The exemption is valid only for the academic semester during which the class project will be conducted, and only after receiving an approval from the IRB Chair, or official designee. It is highly recommended that faculty supervisors of class projects and student research involving human participants obtain the student investigators signatures on the CCGA IRB Application for Extension, Revision, Completion, and Annual Review of Research Investigations when students are initially requesting approval for class projects or research involving human participants, so that the investigation can be closed out at the end of the semester (or upon completion if a research investigation). B. Ethical Responsibility of Instructors: Course instructors have primary responsibility for ensuring that the rights and welfare of human participants are not violated. This responsibility includes communicating to students the ethical principles for the protection of human subjects, reviewing student class project applications, monitoring their activities and consent procedures. All adverse and unexpected incidents involving the human participants must be reported immediately to the IRB Administrator, Office of Academic Affairs, extension 279-5965, and in writing to the IRB Chair, <mailto:IRB@ccga.edu> within 48 hours. 1. Instructors are responsible for prior review of student applications to ensure compliance with the above-stated IRB parameters. 2. Instructors must review and approve informed consent procedures. A sample consent form is provided below. 3. Instructors should submit a copy of the consent forms used for each project. 3. Instructors must review and approve instruments, methods, and procedures prior to use by students. 4. Instructors are responsible for ensuring that students obtain authorization for access to other institutions. This is very important! 5. Instructors are responsible for notifying the CCGA IRB upon completion of the classroom projects. C. Sample Format for Consent for Class Projects: NOTE: This consent form is only for use in class projects. This does not meet the minimum necessary federal standards for regular research. 3 1 October 2014